Quite a few devices have been described that offer protections of the soft tissues of the mouth from abrasion by orthodontic braces, but all possess significant drawbacks that have prevented their wide use. One device describes a silicone bracket cap with holes and slits that fit over a bracket and is secured by the main wire, requiring the placement of many caps and a bumpy, irregular feel. Another teaches a silicone shield that employs room temperature setting silicone that is placed in the mouth and allowed to set, then removed from the mouth and trimmed, and inconvenient procedure, and sanitary storage must be employed for re-use of the device.
A flat thermoplastic strip has been described that required heating to between 160-212 degrees Fahrenheit to soften it, whereupon it is pressed onto and molded onto the teeth and braces. A moldable lip guard has been described that must first be heated in hot water. Another disclosure teaches a two-part curable silicone composition that, upon mixing the parts, yields a putty-like consistency that can be molded over the braces before the cure is complete. The mixing and timing aspects of this device also render it inconvenient to use.
A putty-like, moldable material, a product currently on the market, comes in small strips that can be pressed onto the braces to offer protection. This material is a silicone high consistency rubber (HCR) base, well known to those practiced in the art of silicones. However, even when molded onto and into the brackets and wires of orthodontic braces, it adheres poorly if the braces are moist with saliva. Unfortunately, braces are typically very moist with saliva since the presence of braces in the mouth commonly stimulates its excess production, the saliva then acting as a lubricant such that even though molded into and onto the brackets and wires of the braces, the material easily dislodges from the braces. Hence the instructions state “Your brackets must be completely dry for Silicone wax to adhere properly.” This is a difficult state to achieve.
In addition, this material tends to stick more aggressively to the fingers than to the braces if the braces are wet and the fingers are dry, causing the material to pull off the braces during attempted application. What is required is a device that offers protection of the soft tissues of the mouth from abrasion by orthodontic braces that is extremely convenient to use (for example, does not require heating or curing), will work well in a situation where the braces are very wet with saliva, will adhere upon application more aggressively to wet teeth and braces than to dry fingers, and will remain in position during activities such as play, participation in sports, while playing musical instruments that require the mouth, drinking, and eating.